MAUDE Adverse Event Report: CORCYM S.R.L. MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING

Model Number	MRCS30
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown device disposition.
Event or Problem Description
The manufacture was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a memo 3d rechord #30 valve was implanted and explanted on the same day on (b)(6) 2021.No further information about any device malfunction, patient outcome or device finally implanted was received from the site regarding this event.
Event or Problem Description
The manufacture was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a memo 3d rechord #30 valve was implanted and explanted on the same day on (b)(6) 2021.No further information about any device malfunction, patient outcome or device finally implanted was received from the site regarding this event.The manufacturer obtained additional information identifying that the ring was explanted due to a failed complex mitral valve repair.The event was deemed not device related based on the surgeon's assessment.
Additional Manufacturer Narrative
Updated sections: b4, b5, g3, g6, h1, h2, h6 (analysis of production records no longer warranted based on the additional information received).Since the device was reportedly not available for return, an inspection on the device is not possible at this time.However, based on the medical judgment received, the event was deemed not device related.As such, no further investigation is warranted at this time.The root cause of the reported event is attributed to non-device related factors.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• MDR Report Key: 12551097
• Report Number: 3005687633-2021-00157
• Device Sequence Number: 3322710
• Product Code: KRH
• UDI-Device Identifier: 08022057015082
• UDI-Public: (01)08022057015082(240)ICV1333(17)231106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/06/2023
• Device Model Number: MRCS30
• Device Catalogue Number: ICV1333
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR